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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 200327

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NDA 200327 describes TEFLARO, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TEFLARO profile page.

The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.
Summary for 200327
Ingredient:ceftaroline fosamil
Generic Entry Opportunity Date for 200327
Generic Entry Date for 200327*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 200327
Suppliers and Packaging for NDA: 200327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327 NDA Allergan, Inc. 0456-0400 0456-0400-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)
TEFLARO ceftaroline fosamil POWDER;INTRAVENOUS 200327 NDA Allergan, Inc. 0456-0600 0456-0600-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01)
Paragraph IV (Patent) Challenges for 200327
Tradename Dosage Ingredient NDA Submissiondate
TEFLARO POWDER;INTRAVENOUS ceftaroline fosamil 200327 2014-10-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength400MG/VIAL
Approval Date:Oct 29, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 13, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Apr 11, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Dec 15, 2021Product Flag?YSubstance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.